BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3864324 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11321
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Report Date
    May 30, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37713, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PULLING AND PINCHING NEAR THE LEAD WIRE THAT STARTED IN (B)(6) 2013. IT WAS NOTED THAT THE MANUFACTURING REPRESENTATIVE WAS NOTIFIED AROUND (B)(6) 2013 OF THE PINCHING NEAR THE LEAD WIRE. THE REPORTER NOTED THAT REPROGRAMMING HAD HELPED THE PULLING AND PINCHING. THE PATIENT WAS TOLD THAT THE LEAD ISSUE WAS DUE TO WEAR AND ACTIVITY. IT WAS NOTED THAT THE PATIENT WAS REPROGRAMMED THAT THE ELECTRODE AT THE END OF THE LEAD WIRE WAS TURNED OFF. TO FURTHER PREVENT WEAR TO THE LEAD WIRE, THE HEALTH CARE PROFESSIONAL HAD REDUCED THE PATIENT¿S WORK TO 3 DAYS PER WEEK. IT WAS FURTHER REPORTED THAT THE PATIENT WAS SEEN ON (B)(6) 2014 FOR A REPROGRAMMING VISIT. IT WAS NOTED THAT THE PATIENT WAS GIVEN A DIFFERENT OPTION FOR PAIN PROGRAMMING. IT WAS NOTED THAT THE PATIENT BRIEFLY MENTIONED A PINCHING SENSATION. IT WAS NOTED THAT THE PATIENT HAD NO LOSS OF EFFICACY WITH THE STIMULATOR. IT WAS FURTHER REPORTED THAT THE MANUFACTURING REPRESENTATIVE DID NOT MAKE A COMMENT TO THE PATIENT THAT HER LEADS WERE ¿WEARING.¿ THE PATIENT MENTIONED THE PINCHING AND WAS OFFERED A DIFFERENT PROGRAMMING OPTION. REFER TO MANUFACTURING REPORT # 3004209178-2014-11319 FOR REPORT ON PATIENT'S SECOND DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339806 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR